The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities

This study is a prospective, randomized, single-center randomized controlled clinical trial to investigate the safety and efficacy of ondansetron in reducing the toxicity associated with immune checkpoint inhibitor treatment. This study plans to enroll 134 patients with hepatocellular carcinoma who are scheduled to receive standard ICI treatment. This study will adopt the 2023 CSCO Guidelines for the Management of Immune checkpoint inhibitor-related toxicity as the main assessment criterion, and take the incidence and severity of irAEs as the main observation indicators to evaluate the effectiveness of ondansetron in reducing the toxicity related to immune checkpoint inhibitor treatment in patients with hepatocellular carcinoma.

NCT Number	NCT07381634
Lead Sponsor	First Affiliated Hospital of Wenzhou Medical University
Conditions	Hepatocellular Carcinoma (HCC), IrAE
Enrollment	134 participants
Start Date	2026-04-30
Primary Completion	2026-12-20 (estimated)
Study Completion	2027-06-20 (estimated)
Updated on ClinicalTrials.gov	2026-08-04